dailypharmkorea

Company
‘Korea’s low reimb of orphan drugs needs to be improved’
by Eo, Yun-Ho May 03, 2023 05:38am
Study results have shown that Korea has low access to rare disease treatments. The Korean Research-based Pharmaceutical Industry Association (KRPIA) recently announced study results that stress Korea’s need to improve its reimbursement system in consideration of the characteristics held by rare diseases and rare disease treatments based on the ‘Study on the current status of access to rare disease treatments in Korea and measures to strengthen their coverage'. The results were derived from the research Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy conducted as a principal investigator last year on the present status of access to rare disease treatments in Korea and measures to strengthen their coverage. The research analyzed the drugs in terms of usability –designation and marketing authorization of orphan drugs, and accessibility – reimbursement listing and medical expense support. The study pointed out how Korea defines orphan drugs and rare disease drugs separately and gives them different statuses and benefits, and that this disparity leads to the irrational result of drugs that are already approved as orphan drugs being unable to benefit from the system during the reimbursement evaluation process. In Korea, the reimbursement rate for orphan drugs (136) approved during the last decade (2012-2021) was 52.9%. When compared with similar research results overseas, this is a considerably lower level than that in Germany (93%) or France (81.1%). Also, it was noted that the average time required for orphan drugs or anticancer drugs to receive approval in Korea was 27.4 months, compared to 19.5 months in France and 18.6 months in Italy. Also, by analyzing the reimbursement rates of 136 orphan drugs approved in Korea according to special calculation exemption classification status, the study found that rare disease treatments(51.1%) and items ineligible for the special calculation exception (33.3%) showed lower reimbursement rates than anticancer drugs (57.6%). In other words, although the special calculation exemption system reduces the patient's burden for orphan drugs of rare diseases that are designated for special calculations, the system rather acts as an obstacle for diseases that are not subject to the special calculation exemption system that seeks to receive reimbursement. Korea's expenditures on orphan drugs is also 3.6%, which is lower than the OECD median of 6.8%, which is at the lower end among OECD countries. This shows the need for Korea to spend more on orphan drugs.